(127 days)
The Manan™ General Utility Drainage Catheter is for percutaneous nephrostomy, abcess, cyst, and other small fluid collection drainage.
Manan drainage catheters are made from a biocompatible implantable urethane (Tecoflex) that has been used extensively in both short and long term implantable medical devices. This material softens at body temperature thus minimizing tissue trauma. The catheters come in various end configurations: Pigtailloop(Locking and non-locking), and "J" type. Also included with the catheters are stiffening cannula and trocar sets.
The provided document is a 510(k) summary for the Manan™ General Utility Drainage Catheter. It primarily focuses on demonstrating substantial equivalence to a predicate device for marketing purposes. This type of regulatory submission does not typically include detailed performance studies with acceptance criteria in the same way a clinical trial or a novel AI/software medical device submission would.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in this document. This submission relies on demonstrating similarity to an already approved device rather than presenting new performance data against specific, pre-defined acceptance criteria.
However, I can extract the information that is available:
1. A table of acceptance criteria and the reported device performance
This document does not define specific "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy, as it is a 510(k) submission for a physical medical device (a drainage catheter) based on substantial equivalence, not a software or AI device. The "performance" demonstrated is primarily through comparison to a predicate device.
2. Sample size used for the test set and the data provenance
Not applicable. There is no "test set" in the context of performance evaluation for an AI or diagnostic device. The substantial equivalence is based on device description (materials, configurations, intended use) to an existing predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no ground truth establishment in this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical medical device, not an AI or diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
Summary of available information relevant to "performance" in this 510(k) context:
The document describes the device's technical characteristics and intended use, comparing it to an already approved device to demonstrate substantial equivalence.
- Identified Predicate Device: Manan Medical Products General Utility Drainage Catheter (K953713)
- Device Description:
- Made from biocompatible implantable urethane (Tecoflex).
- Material softens at body temperature.
- Comes in various end configurations: Pigtail-loop (locking and non-locking), and "J" type.
- Includes stiffening cannula and trocar sets.
- Indications for Use: Percutaneous nephrostomy, abscess, cyst, and other small fluid collection drainage.
The "study" in this context is the submission of documentation to the FDA demonstrating that the new device is sufficiently similar to the predicate device in terms of materials, design, technological characteristics, and intended use to be considered safe and effective for its stated purpose. This does not involve clinical performance data or AI model evaluation.
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Image /page/0/Picture/1 description: The image shows the logo for MDTECH Medical Device Technologies Inc. The logo is black and white and features the letters "MDTECH" in a bold, sans-serif font. Below the letters is the text "MEDICAL DEVICE TECHNOLOGIES INC." in a smaller font. The logo is simple and modern.
MAY 27 1998
4445-310 S.W. 35th Terrace Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662
510(k) SUMMARY
| APPLICANT: | Medical Device Technologies, Inc.4445-310 SW 35th TerraceGainesville, FL 32608 |
|---|---|
| CONTACT: | Karl SwartzQuality Assurance Manager |
| TELEPHONE: | (352)338-0440fax (352)338-0662 |
| TRADE NAMES: | Manan™ General Utility Drainage Catheter |
| COMMON NAME: | Drainage catheter |
| CLASSIFICATION NAME: | §878.4200-Introduction Drainage Catheter and Accessorie |
| SUBSTANTIAL EQUIVALENCE: |
General Utility Drainage Catheter Manan Medical Products K953713
DESCRIPTION OF DEVICE:
Manan drainage catheters are made from a biocompatible implantable urethane (Tecoflex) that has been used extensively in both short and long term implantable medical devices. This material softens at body temperature thus minimizing tissue trauma. The catheters come in various end configurations: Pigtailloop(Locking and non-locking), and "J" type. Also included with the catheters are stiffening cannula and trocar sets.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol consists of three abstract human profiles facing right, layered on top of each other. The profiles are rendered in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 7 1998
Mr. Karl Swartz ·Quality Manager Medical Device Technologies Incorporated 4445-310 South West 35th Terrace Gainesville, Florida 32608
K980193 Re: Manan™ General Utility Drainage Catheter Trade Name: Regulatory Class: II Product Code: LJE Dated: April 16, 1998 Received: April 17, 1998
Dear Mr. Swartz:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 54.2 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Swartz
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification.for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Colia M. Whitten, Ph.D., M.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/1 description: The image is a logo for MDTECH Medical Device Technologies Inc. The logo is black and white and features the company name in a bold, sans-serif font. The letters "MDTECH" are stacked on top of the words "MEDICAL DEVICE TECHNOLOGIES INC". The logo is simple and modern, and it is likely used on the company's website, marketing materials, and products.
445-310 S.W. 35th Terrace Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662
Page_1_of_1_
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Manan™ General Utility Drainage Catheter
Indications for Use:
The Manan™ General Utility Drainage Catheter is for percutaneous nephrostomy, abcess, cyst, and other small fluid collection drainage.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Office Evaluation (cont.)
(Division Sign-Off)
Division of General Read 5 I U(k) Number
Prescription Use_X (Per 21 CFR 801.109) OR
Over-The-Counter Use_
(Optional Format 1-2-96)
N/A